21:10 , Dec 30, 2016 |  BC Week In Review  |  Clinical News

Anagrelide CR regulatory update

Galena said FDA confirmed that a Phase III trial comparing anagrelide CR vs. best available therapy in patients with essential thrombocythemia would be appropriate for an NDA submission using the 505(b)(2) pathway. The trial, which...
07:00 , Jun 22, 2015 |  BC Week In Review  |  Clinical News

Anagrelide CR: Updated Phase II data

Updated data from an open-label, U.S. Phase II trial in 18 patients with elevated platelet counts secondary to essential thrombocythemia and other myeloproliferative neoplasms showed that twice-daily oral GALE-401 led to an overall response rate...
07:00 , Jun 15, 2015 |  BC Week In Review  |  Clinical News

Anagrelide CR: Additional Phase II data

Additional data from an open-label, U.S. Phase II trial in 18 patients with elevated platelet counts secondary to essential thrombocythemia and other myeloproliferative neoplasms showed that twice-daily oral GALE-401 led to an overall response rate...
08:00 , Jan 26, 2015 |  BC Week In Review  |  Clinical News

Anagrelide CR: Preliminary Phase II data

Preliminary data from an open-label, U.S. Phase II trial in 18 patients with elevated platelet counts secondary to essential thrombocythemia and other myeloproliferative neoplasms showed that twice-daily oral GALE-401 led to a confirmed or unconfirmed...
08:00 , Dec 8, 2014 |  BC Week In Review  |  Clinical News

Anagrelide CR: Completed Phase II enrollment

Galena completed enrollment of 18 patients with elevated platelet counts secondary to essential thrombocythemia and other myeloproliferative neoplasms in an open-label, U.S. Phase II trial of oral GALE-401 twice daily for =24 weeks. Patients will...
07:00 , Sep 22, 2014 |  BC Week In Review  |  Clinical News

Anagrelide CR: Phase II started

Galena began an open-label, U.S. Phase II trial to evaluate oral GALE-401 twice daily for >=24 weeks in about 20 patients with elevated platelet counts secondary to essential thrombocythemia and other myeloproliferative neoplasms. Patients will...
08:00 , Jan 20, 2014 |  BC Week In Review  |  Company News

Galena Biopharma, Mills Pharmaceuticals deal

Galena acquired Mills Pharmaceuticals for about $1.6 million cash up front. Galena gains exclusive, worldwide rights to anagrelide CR ( GALE-401 ), a controlled-release formulation of generic anti-platelet therapy anagrelide. Former Mills shareholders are eligible...